a single-dose study to investigate the pharmacokinetics of mk-7655 in participants with impaired renal function (mk-7655-005)

Conditions: Infectious Disease

Summary: this is a 2-part study of the pharmacokinetics (pk) of mk-7655. in part i, the pk of a single 125 mg dose of mk-7655 given in combination with 250 mg of primaxin® (imipenem + cilastatin) will be determined in participants with impaired renal function and matched control participants. in part ii, the potential for renal insufficiency to affect non-renal clearance mechanisms will be investigated.


Eligibility criteria:
inclusion criteria * participants of reproductive potential (male or female) must be willing to use contraception. * body mass index (bmi) ≤40 kg/m\^2 * weight \>60 kg at screening visit * no clinically significant abnormality on electrocardiogram (ecg) at screening visit and/or prior to administration of the initial dose of study drug * panels a-d: smokers will be limited to no more that 10 cigarettes per day. * panels e-h: nonsmoker or has not used nicotine for at least 6 months * in good health (stable health for participants with renal impairment) exclusion criteria * pregnant or breastfeeding. * history of recent stroke, chronic seizures, or major neurological disorder * history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary abnormalities or diseases * history of malignant neoplastic disease. exceptions: (1) adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix; (2) other malignancies that have been successfully treated ≥10 years prior to the screening visit * panels a-d: use of any medication (prescription or non-prescription) or herbal remedies (such as st. john's wort \[hypericum perforatum\]) beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug to the post study visit * panels e-h: use of any medication (prescription or non-prescription) or herbal remedies (such as st. john's wort \[hypericum perforatum\]) that are inhibitors or inducers of cyp1a2, cyp2c19, cyp34a, or substrates of cyp2c19, beginning approximately 2 weeks (or 5 half-lives) prior to administration of the probe cocktail, until the post-study visit * consumption of greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[284 ml/10 ounces\], wine \[125 ml/4 ounces\], or distilled spirits \[25 ml/1 ounce\]) per day * consumption of greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day * major surgery, donation or loss of 1 unit of blood (approximately 500 ml), or participation in another investigational study within 4 weeks prior to the screening visit * history of multiple and/or severe allergies (including latex allergy), or prior anaphylactic reaction or intolerability to prescription or non-prescription drugs or food * history of hypersensitivity to primaxin® iv or other beta lactam antibiotic (including but not limited to penicillins, cephalosporins, monobactams and carbapenems) * regular user (including recreational use of drugs \[including alcohol\]) within approximately 12 months of screening visit * history of kidney removal and/or renal transplant * history of clostridium difficile colitis or known c. difficile colonization